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The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in increasing doses. How long the drug remains in the body will also be calculated.
Approximately 18 healthy subjects will be randomized to receive by mouth either 3 single increasing doses of CC100 or 1 dose of placebo and 2 increasing doses of CC100. Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. Subjects are required to stay in the Clinic for approximately 24 hours following each dose. Subjects may choose to have an optional lumbar puncture following the 3rd dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC100 (3 single doses) | Experimental | CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. |
|
| CC100 (2 single doses) & placebo(1 dose) | Experimental | CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC100 | Drug | CC100 reconstituted in diluent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unsolicited Adverse Event Reports | Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose. | Minimum of 24 hours after each dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100 |
| Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Pascuzzi, MD | IU Health Physicians - Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Neuroscience Center | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CC100 (3 Single Doses) | CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. CC100 |
| FG001 | CC100 (2 Single Doses) & Placebo(1 Dose) | CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. CC100 Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CC100 (3 Single Doses) | CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. CC100 |
| BG001 | CC100 (2 Single Doses) & Placebo(1 Dose) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Unsolicited Adverse Event Reports | Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose. | All 18 subjects analyzed, per protocol. | Posted | Number | Unsolicited Adverse Event Reports | Minimum of 24 hours after each dose. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CC100 (3 Single Doses) | CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. CC100 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Consultant | Chemigen | 317 293-0852 | farlowds@yahoo.com |
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| Placebo | Drug | Diluent. Amount to match CC100 dose. |
|
|
| 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100 |
CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
CC100
Placebo
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
| Secondary | Pharmacokinetics (PK) | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant. | Posted | Mean | Standard Error | hours | 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100 |
|
|
|
| Secondary | Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant. | Posted | Mean | Standard Error | hours | 0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100 |
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| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | CC100 (2 Single Doses) & Placebo(1 Dose) | CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. CC100 Placebo | 0 | 9 | 4 | 9 |
| urinary tract infections | Infections and infestations | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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